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FOR IMMEDIATE RELEASE
July 21, 2003
CASE SERIES IN JOURNAL OF INVASIVE CARDIOLOGY DESCRIBES THE ROLE OF PHARMANETICS’ ENOX TEST IN MANAGING FOUR PATIENTS TREATED WITH ENOXAPARIN
Highlights Usefulness of ENOX and Enoxaparin in the Management of Patients with Acute Coronary Syndromes
Raleigh, NC (July 21, 2003) – The series, submitted by Dr. Jose G. Diez, Assistant Professor of Medicine, Director Interventional Cardiology Research, and colleagues at Tulane University Health Sciences Center, New Orleans, was presented in the July 2003 issue of the Journal of Invasive Cardiology and further validates the value of PharmaNetics’ ENOX test in detecting the anticoagulant effects of enoxaparin in patients who undergo percutaneous coronary intervention (PCI). The cases describe various treatment strategies for managing acute coronary syndromes (ACS) patients with enoxaparin using the test to confirm that the patients were adequately anticoagulated. Using various dosing strategies, all patients eventually achieved ENOX clotting times of >260 seconds and successfully underwent PCI, illustrating the tests’ usefulness in helping physicians achieve the ideal level of anticoagulation. As with an earlier case reported in May by Dr. Sai Sadanandan and colleagues at Oklahoma University Health Sciences Center, it further describes the importance of the ENOX test when used to monitor the enoxaparin level in patients who may not have achieved steady-state levels of anticoagulation with subcutaneous dosing (i.e. more than three doses or, according to the studies by Collet et al and the PEPCI investigators, at least four subcutaneous doses).
Commenting on the use of the test, Dr. Diez said, “Enoxaparin has been demonstrated to be superior in the medical and upstream management of ACS patients. However, the transition of this therapeutic agent to the interventional arena has been slow due to concerns among interventionists in using low molecular weight heparins without the availability of a “routine assay” to monitor the level of anticoagulation. Before the introduction of the ENOX test, it could take several hours to receive the results from the central laboratory, and waiting for these results prior to PCI is not feasible. The introduction of this new test now gives interventionists an important point-of-care tool to rapidly monitor enoxaparin levels in the catheterization laboratory and should address the concerns of physicians when using the drug in many clinical situations.” He added, “We have used the test in our clinical practice to collect data on over 75 patients and have found it very useful in assessing adequate anticoagulation prior to PCI in different groups of patients receiving subcutaneous enoxaparin. In those patients with subtherapeutic levels for PCI, the test also aids in evaluating the response to “booster” intravenous doses of enoxaparin (0.3 mg/kg i.v.).” We will be presenting our data at the Transcatheter Cardiovascular Therapeutics Meeting (TCT) in September.”
“The test is now in use at a number of leading heart centers. We anticipate that these reference sites, in conjunction with published reports, will continue to both demonstrate that the test can make a contribution to improved patient safety and help us to expand the use of the technology,” said, Michael Riddle, executive vice president of PharmaNetics. He added, “Data from our ELECT trial was presented last week at the International Society Thrombosis and Hemostasis Meeting, giving more exposure to the ENOX test ranges established for the safe performance of PCI and sheath removal. In addition, as the use of enoxaparin expands, there may be many occasions where a patient is transferred from another facility and the actual time of drug administration is unclear. We believe that, under these circumstances, there will be a growing need for the test to be used to confirm that the patient actually received the drug.”
PharmaNetics, Inc. (NASDAQ/NM: PHAR), a leading biotech company, conceived the term “theranostics,” defining an emerging new field of medicine that enables physicians to monitor the effect of antithrombotic agents in patients being treated for angina, myocardial infarction (heart attack), stroke, and pulmonary and arterial emboli. The Company develops, manufactures and markets rapid turnaround diagnostics to assess blood clot formation and dissolution. PharmaNetics develops tests based on its proprietary, dry chemistry Thrombolytic Assessment System. Its principal target market is the management of powerful new drug compounds, some of which may have narrow therapeutic ranges, as well as monitoring routine anticoagulants.
This press release contains forward-looking statements regarding future events and the future performance of PharmaNetics that involve risks and uncertainties such as risks related to market acceptance, clinical trials and dependence on third-party distributors and collaborative partners that could cause actual results to differ materially from those projected in the forward-looking statements. Information concerning these and other of the factors that could cause results to differ materially from those in the forward-looking statements is contained in the Company’s filings with the Securities and Exchange Commission, including Form 10-K, Form 10-Q and Form 8-K reports.
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